BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1210120 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05441
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT WHEN CLIPPING A BLEEDING OF THE LOWER ESOPHAGUS, THE CLIP DID NOT COME LOOSE FROM THE RESOLUTION CLIP DEVICE. THE CLIP HAD TO BE REMOVED WITH FORCE FROM THE MUCOSA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML7120609

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK